Kenya is set to update its national treatment guidelines for kala-azar after the World Health Organisation (WHO) endorsed new improved treatments for leishmaniasis in Eastern Africa marking revision of the global recommendations in nearly two decades.
The updated WHO guidelines introduce shorter, safer and more effective treatment regimens for visceral leishmaniasis (VL), commonly known as kala-azar, and post-kala-azar dermal leishmaniasis (PKDL), replacing lengthy injection-based therapies with a combination that includes an oral medicine for the first time in the region.
The revised recommendations are based on clinical trials conducted at Kacheliba Sub-County Hospital in Kenya led by the Drugs for Neglected Diseases initiative (DNDi) in partnership with the Ministry of Health and other partners. Trials were also conducted in Uganda, Ethiopia, and South Sudan.
Welcoming the endorsement, Head, Division of Vector Borne & Neglected Tropical Diseases at the Ministry of Health, Kenya, Wyckliff Omondi said the government is working to incorporate the new treatments in the country’s national treatment guidelines, so that patients can benefit from them as soon as possible.
“Now that the WHO has updated its treatment guidelines, we are working also to include the new treatments in our national guidelines, so our patients can benefit from them as soon as possible,” Omondi said.
Adding that: “Kenya has been an active partner in the development of these new treatments through the Leishmaniasis East Africa Platform (LEAP), and we are hopeful that all our joint efforts will lead to the elimination of this terrible disease.”
The new WHO recommendations include for the first time in the region an oral drug. Patients with kala-azar or PKDL will receive oral miltefosine plus a once-daily paromomycin injection for just 14 days: from 34 injections down to 14 for kala-azar, and from 60–90 injections down to just 14 for PKDL.
WHO says kala-azar is one of the world’s deadliest parasitic diseases after malaria, and fatal in 95% of cases if untreated. In 2024, Eastern Africa accounted for 79% of global kala-azar cases, with half of all patients being children under 15.
In Kenya alone, the treatments are expected to benefit patients in 11 kala-azar endemic counties by reducing painful injections, shortening hospital stays and improving treatment outcomes.
“Until now, treatment for kala-azar meant enduring 34 painful injections over 17 days and PKDL treatment required 60–90 days. The new WHO recommendations include for the first time in the region an oral drug. Patients with kala-azar or PKDL will receive oral miltefosine plus a once-daily paromomycin injection for just 14 days: from 34 injections down to 14 for kala-azar, and from 60–90 injections down to just 14 for PKDL,”
The new regimens recommended for VL and PKDL in eastern Africa are free from sodium stibogluconate (SSG), long known for its painful injections and severe toxicities, replacing it for the first time with an oral drug, miltefosine (MF).
In South Asia, new recommended treatment options for people with PKDL are now shorter and safer, with liposomal amphotericin B (LAmB) alone or in combination with MF. The guidelines also provide guidance for the management of VL relapse in South Asia.
These new therapies recommended for VL and PKDL in eastern Africa and some of the recommended alternative regimens for PKDL in South Asia were developed by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) and partners.
“For too long, patients suffering from leishmaniasis have endured treatments nearly as punishing as the disease itself. These new WHO guidelines mark a turning point,” said Dr Daniel Ngamije Madandi, WHO Director of Malaria and Neglected Tropical Diseases. “By recommending safer, shorter, and more patient friendly regimens, we are not just improving care; we are accelerating our fight to eliminate this devastating disease and offering renewed hope to communities across Africa and Asia.”
According to a statement, the disease is endemic in 80 countries, with 50,000 to 90,000 new cases estimated to occur each year, while only 25–45% are reported to WHO.
PKDL is a skin condition that can develop months after successful kala-azar treatment. Though not life threatening, it is highly stigmatizing, and many people living with PKDL face social isolation and mental health challenges. PKDL can also contribute to ongoing transmission of VL in affected communities.
The new treatments will significantly improve the standard of care for patients with leishmaniasis, ahead of the expected arrival in the coming years of even more patient-friendly, innovative oral therapeutic options now in development. This includes LXE408, a novel oral candidate for leishmaniasis that DNDi is jointly developing with Novartis
“We are delighted that more patient-friendly treatments developed with our partners have been included in the WHO guidelines,’ said Dr Fabiana Alves, Leishmaniasis-Mycetoma Cluster Director at DNDi. ‘These advances are important steps towards elimination, but we are already looking ahead. We are now working with Novartis and partners on the development of LXE408, a promising new oral candidate that could help us soon finally move away from injectable regimens.”
Kala-azar
VL, also known as kala-azar (‘black fever’ in Hindi), is transmitted by the bite of an infected sandfly and is one of the world’s deadliest parasitic killers after malaria. It causes high fever, weight loss, anaemia, spleen and liver enlargement, and, if not treated, death.
PKDL is a related skin condition that can appear months after kala-azar treatment. It causes visible lesions that often lead to social stigma, isolation, and significant emotional distress.
